Accuracy parameters of PCCE-2 in detecting colonic polyps as compared to conventional colonoscopy [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]

Assessment of colon cleansing level at different colon segments [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]

Distribution of capsule excretion time [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]

Percent of excreted capsules up to 10 hours post capsule ingestion. [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]

Number, type and severity of adverse events [ Time Frame: WithIn 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Accuracy parameters of PCCE-2 in detecting colonic lesions as compared to conventional colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Capsule transit time within stomach, small bowel and colon [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Number of polyps and sizes at different colon segments detected by capsule [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Number of polyps and sizes at different colon segments detected by conventional colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

RAPID video reading time [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]

Conventional colonoscopy duration including: total time, insertion time, and withdrawal time see my comment above (at the objective section) [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]

Assessment of the RAPID video [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]

Patient questionnaire [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]

The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.

The PillCam™ SB capsule (formerly M2A® Capsule) that was cleared by the FDA- in August 2001 for small bowel evaluation has been ingested to date by more than 500,000 people worldwide and is well accepted by patients and physicians as well as the professional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. To date, several clinical studies have been conducted with PillCam™ Colon Endoscope 1(PCCE-1) system. The new development of PillCam Colon Endoscope 2 (PCCE-2) is primarily aimed to increase sensitivity and specificity for polyp detection.

Further details of the PillCam™ Colon Capsule Endoscope (PCCE-2) can be found in the device description section.

This study is designed to evaluate the performance of the new version of colon capsule and its performance in detecting lesions in the colon as compared to conventional colonoscopy.

Eligibility

Ages Eligible for Study:

18 Years to 57 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.

Criteria

Inclusion Criteria:

Subject is between the ages of 18-57 years.

Subject is able and agrees to sign the Informed Consent Form

Subject was referred to colonoscopy for at least one of the following reasons:

Personal history of colorectal cancer (CRC) or adenomatous polyps and at least 5 years since last conventional colonoscopy

Positive findings in the colon

Personal history of polyps that were removed at least 5 years ago (5 years and more)

Exclusion Criteria:

Subject has dysphagia

Subject has congestive heart failure

Subject has renal insufficiency

Subject has Nephrotic syndrome

Subject has Cirrhosis

Subject is known or is suspected to suffer from intestinal obstruction.

Subject is taking NSAID medication

Subject suffers from hypertension and is taking one or more of the following medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers

Chronic use of laxatives

Subject has a cardiac pacemakers or other implanted electro medical devices.

Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.

Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.

Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.

Subject has any condition, which precludes compliance with study and/or device instructions.

Age < 18 years or under parent guardian

Age>57 years

Subject suffers from life threatening conditions

Subject is currently participating in another clinical study

Subject has known slow gastric emptying time

Subject is allergic or contraindicated to any of the study medications

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884624